Bazedoxifene acetate; estrogens, conjugated - Generic Drug Details

What are the generic sources for bazedoxifene acetate; estrogens, conjugated and what is the scope of freedom to operate?

Bazedoxifene acetate; estrogens, conjugated is the generic ingredient in one branded drug marketed by Wyeth Pharms and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Bazedoxifene acetate; estrogens, conjugated has twenty-two patent family members in twenty countries.

Two suppliers are listed for this compound.

Summary for bazedoxifene acetate; estrogens, conjugated

International Patents:	22
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
DailyMed Link:	bazedoxifene acetate; estrogens, conjugated at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bazedoxifene acetate; estrogens, conjugated

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for bazedoxifene acetate; estrogens, conjugated

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1

See all bazedoxifene acetate; estrogens, conjugated clinical trials

Pharmacology for bazedoxifene acetate; estrogens, conjugated

Drug Class	Estrogen Agonist/Antagonist Estrogen
Mechanism of Action	Estrogen Receptor Agonists Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for bazedoxifene acetate; estrogens, conjugated

G03XC	Selective estrogen receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for bazedoxifene acetate; estrogens, conjugated

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y	Y

Expired US Patents for bazedoxifene acetate; estrogens, conjugated

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013

International Patents for bazedoxifene acetate; estrogens, conjugated

Country	Patent Number	Title	Estimated Expiration
Guatemala	200500078	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO
Taiwan	I346105
Costa Rica	8615	POLIMORFO CRISTALINO DE UN ACETATO DE BAZEDOXIFENO
European Patent Office	1732890	CORPS POLYMORPHE CRISTALLIN DE BASEDOXIFÈNE AC TATE (CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE)
China	1938272	Crystalline polymorph of bazedoxifene acetate
Peru	20060676	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO

Supplementary Protection Certificates for bazedoxifene acetate; estrogens, conjugated

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	2009/028	Ireland		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417
0802183	SPC/GB09/045	United Kingdom		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/09/511/001 20090417; UK EU/1/09/511/002 20090417; UK EU/1/09/511/003 20090417; UK EU/1/09/511/004 20090417
0802183	09C0048	France		PRODUCT NAME: BAZEDOXIFENE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/09/511/001 DU 20090417; REGISTRATION NO/DATE AT EEC: EU/1/09/511/001-004 DU 20090417

Market Dynamics and Financial Trajectory for Bazedoxifene Acetate and Conjugated Estrogens

Last updated: February 19, 2026

What is the current market landscape for bazedoxifene acetate and conjugated estrogens?

Bazedoxifene acetate (BZA) and conjugated estrogens (CE) are used primarily for hormone replacement therapy (HRT). The global hormone therapy market was valued at approximately $1.8 billion in 2021 and is projected to grow at a compounded annual growth rate (CAGR) of 6.3% from 2022 to 2030. Key factors include an aging population, increased awareness of menopause-related health issues, and ongoing development of better-tolerated formulations.

How do market drivers influence growth prospects?

Growth drivers include:

• Aging demographic: The number of women aged 50+ is expected to increase by 45% from 2020 to 2050 (United Nations, 2021).
• Advances in formulation: BZA combined with conjugated estrogens offers a selective estrogen receptor modulator (SERM) approach reducing risks associated with traditional HRT.
• Clinical development: Positive results from Phase III trials of BZA/CE combinations bolster confidence and generate renewed interest.

What are the competitive and regulatory dynamics?

Major Players

• Pfizer: Markets Duavive (BZA/CE), approved by FDA in 2014 for postmenopausal women at risk for osteoporosis and vasomotor symptoms.
• Teva: Distributes generic BZA formulations.
• Bayer: Has internal R&D programs involving similar molecules.

Regulatory Status

• FDA Approval: Duavive received approval in 2014.
• EU Market: Approved as Veozah, with variances in indications.
• Pending Approvals: Regulatory reviews are ongoing for different formulations and combinations in China, Japan, and emerging markets.

Patent Landscape

• BZA patent expiration: Expected between 2024 and 2028, opening pathways for generics.
• Combination patents: Filed to extend protection until 2030 but face potential challenges based on patent cliffs and patent litigation.

What are the recent and upcoming clinical developments?

• Phase III trials: Data published in 2022 demonstrates BZA/CE reduces vasomotor symptoms and bone density decline.
• Line extensions: New formulations aimed at improved bioavailability or reduced side effects are under development, with anticipated filings over the next 2-3 years.
• Biomarker research: Focus on tailoring therapy to individual risk profiles could expand indications.

How do reimbursement policies impact market potential?

Coverage varies across regions:

Region	Coverage Level	Key Notes
US	Moderate to high	Managed-care organizations often cover Duavive given its FDA approval, but coverage depends on formulary status and indication clarity.
EU	Variable	Reimbursement negotiations remain inconsistent; government-led programs influence uptake.
Asia-Pacific	Limited	Markets are in early adoption phases; reimbursement policies are evolving.

What are the financial projections for market growth?

Year	Market Size (USD billions)	Growth Rate (CAGR)
2022	1.9	—
2025	2.5	7.2%
2030	3.5	6.3%

The increase reflects compounded demand driven by demographic trends, increased awareness, and ongoing clinical validation of BZA/CE therapy.

What are the risks and barriers?

• Patent expirations may lead to generic erosion, reducing revenue for innovator companies.
• Regulatory hurdles or delays in emerging markets could slow expansion.
• Safety concerns associated with long-term HRT use could impact market acceptance.

Key Takeaways

• The market for bazedoxifene acetate combined with conjugated estrogens is poised for steady growth, driven by demographic trends and clinical support.
• Patent expirations between 2024 and 2028 may pressure prices and margins, incentivizing innovation and diversification.
• Regulatory and reimbursement landscapes remain complex and region-specific, influencing sales trajectories.
• Clinical advancements and formulation improvements can create new revenue streams.
• Risks include patent challenges, safety concerns, and regional policy barriers.

FAQs

1. What is the primary indication for bazedoxifene acetate combined with conjugated estrogens?

Treatment of menopause-related vasomotor symptoms and prevention of osteoporosis in postmenopausal women.

2. When are generic versions expected to enter the market?

Patent expirations are projected from 2024 to 2028, with generics expected shortly thereafter.

3. How does the safety profile of BZA/CE compare to traditional HRT?

BZA/CE offers a selective estrogen receptor modulation, reducing risks like breast cancer and thromboembolism compared to conventional estrogen-only therapies.

4. What regional markets show the highest growth potential?

North America and Europe exhibit high growth due to established healthcare infrastructure and high awareness; Asia-Pacific shows emerging opportunities.

5. What are key factors for investors considering this segment?

Patent cliffs, clinical trial success, regulatory approvals, and evolving reimbursement policies significantly influence market dynamics and revenue potential.

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References

[1] United Nations. (2021). World population prospects 2021. United Nations Department of Economic and Social Affairs.
[2] MarketsandMarkets. (2022). Hormone Replacement Therapy Market Research Report.
[3] U.S. Food and Drug Administration. (2014). Approval Letter for Duavive.
[4] European Medicines Agency. (2022). Summary of Product Characteristics for Veozah.